Ranitidine Under Scanner Again: DTAB, CDSCO Recommend New Safety Study, Tighter Monitoring
New Delhi: Amid continued global concerns over the presence of N-nitrosodimethylamine (NDMA) impurities in ranitidine, the Drugs Technical Advisory Board (DTAB) has recommended a fresh, in-depth safety assessment of the drug. It has advised the Indian Council of Medical Research (ICMR) to conduct a detailed study evaluating the safety risks associated with NDMA, while also recommending that the Central Drugs Standard Control Organisation (CDSCO) constitute a larger expert committee to examine contributing factors such as storage conditions and impurity formation.
The matter was discussed during the 92nd DTAB meeting held on April 24, 2025. “The Board was apprised about the agenda along with report of expert committee constituted for this purpose,” the meeting minutes noted. DTAB observed that the key issue was related to the presence of N-nitrosodimethylamine (NDMA) — a probable human carcinogen — in ranitidine formulations.
Following detailed deliberation, the Board recommended the constitution of a larger committee to holistically examine all aspects of the safety profile of ranitidine, particularly the factors contributing to NDMA formation, including storage and stability.
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